5 results
·
58ms
·
Sources: EU EUDAMED, US FDA
JARVIK 2000 LVAD
FDA Adverse Event
Malfunction
·JARVIK HEART, INC.·Product code DSQ·February 1, 2005
*
FDA Adverse Event
Death
·JARVIK HEART, INC.·Product code DSQ·September 5, 2012
JARVIK 2000
FDA Adverse Event
Death
·JARVIK HEART, INC·Product code DSQ·April 12, 2017
Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
FDA Recall
Terminated
·Jarvik Heart Inc·Product code DSQ·October 15, 2018
Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
FDA Enforcement
Class II
·Terminated·Jarvik Heart Inc·December 26, 2018